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Introduction
PPCE carries out Clinical Data Management activities for paper-based, electronic data capture trials as well as hybrid studies.
PPCE also caters to biostatistics requirements for clinical studies, enabling a one-point- contact for a reliable and high-quality biometrics solution, comprising of both data management and biostatistical analysis.
Our DM and Biostatistics teams work closely together from the beginning of a study in order to identify areas that will affect analysis outputs. In this way, we are able to fashion workflows right from the start to ensure efficient, on-time analysis with minimal rework, which translates into higher efficiency levels and greater cost savings for both parties.
Some of the main benefits of employing PPCE's services are:
- Reliability
- A long-standing culture of quality
- On-time delivery
- Adherence to commitments
- Transparent work practices
- Flexible, cost effective and customer focused methodologies and models
Standard Operating Procedures (SOPs) followed by PPCE incorporate current applicable regulatory requirements and are audited on a regular basis for completeness, applicability and compliance. SOPs include requirements from the stage of protocol finalization, CRF design and database design and testing to data validation, discrepancy management, SAE reconciliation, database audit, lock and archiving, data extraction, interim and final data analysis plans, generation of statistical reports, integrated data summaries, Quality Assurance, Quality Control and archiving and documentation.
Considering that the final goal of our services is to allow for logical and accurate analysis of data that will enable quick and easy regulatory approvals, we pay particular attention to regulatory compliance. 21 CFR part 11, ICH-GCP and GCDMP requirements are built into operating procedures and checked at regular intervals to ensure that your clinical trial data is in safe hands.
Paper Based Studies
Electronic Data Capture
Hybrid Services
CDISC Services
PPCE also caters to biostatistics requirements for clinical studies, enabling a one-point- contact for a reliable and high-quality biometrics solution, comprising of both data management and biostatistical analysis.
Our DM and Biostatistics teams work closely together from the beginning of a study in order to identify areas that will affect analysis outputs. In this way, we are able to fashion workflows right from the start to ensure efficient, on-time analysis with minimal rework, which translates into higher efficiency levels and greater cost savings for both parties.
Some of the main benefits of employing PPCE's services are:
- Reliability
- A long-standing culture of quality
- On-time delivery
- Adherence to commitments
- Transparent work practices
- Flexible, cost effective and customer focused methodologies and models
Standard Operating Procedures (SOPs) followed by PPCE incorporate current applicable regulatory requirements and are audited on a regular basis for completeness, applicability and compliance. SOPs include requirements from the stage of protocol finalization, CRF design and database design and testing to data validation, discrepancy management, SAE reconciliation, database audit, lock and archiving, data extraction, interim and final data analysis plans, generation of statistical reports, integrated data summaries, Quality Assurance, Quality Control and archiving and documentation.
Considering that the final goal of our services is to allow for logical and accurate analysis of data that will enable quick and easy regulatory approvals, we pay particular attention to regulatory compliance. 21 CFR part 11, ICH-GCP and GCDMP requirements are built into operating procedures and checked at regular intervals to ensure that your clinical trial data is in safe hands.
Paper Based Studies
Electronic Data Capture
Hybrid Services
CDISC Services
Contact Info
Address:
502, The Chambers, 4/12/13 Viman Nagar
Pune
Maharashtra 411014
India
Pune
Maharashtra 411014
India
Tel:
020-26745000, 020-26745001
Fax:
020-26745028
Website:
http://www.ppceworld.com
Offering
- Clinical Data Management
Hours of operation
| From | To | From | To | From | To | ||
|---|---|---|---|---|---|---|---|
| Monday | Open | 9.00am | 6.00pm | ||||
| Tuesday | Open | 9.00am | 6.00pm | ||||
| Wednesday | Open | 9.00am | 6.00pm | ||||
| Thursday | Open | 9.00am | 6.00pm | ||||
| Friday | Open | 9.00am | 6.00pm | ||||
| Saturday | Open | ||||||
| Sunday | Open | ||||||
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